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Monoclonal Antibodies

Extension: Dose 2 for Vitiligo

Phase 2
Recruiting
Research Sponsored by Merck Sharp & Dohme LLC
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Has non-segmental vitiligo with disease duration of at least 6 months
Has a clinical diagnosis of non-segmental vitiligo
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline and week 24
Awards & highlights

Study Summary

This trial studies the effectiveness and safety of a new treatment for vitiligo, a skin disorder causing discoloration.

Who is the study for?
This trial is for individuals with non-segmental vitiligo, which causes loss of skin color in blotches. Participants must have had the condition for at least 6 months and show a certain amount of facial and body depigmentation. Those with hands and feet involvement or other forms of vitiligo are not eligible.Check my eligibility
What is being tested?
The study tests MK-6194 against a placebo to see if it's better at improving the appearance of vitiligo on the face after 24 weeks. The main goal is to check how much this treatment can change the extent of skin color loss compared to no active treatment.See study design
What are the potential side effects?
While specific side effects for MK-6194 aren't listed here, common ones in trials may include skin irritation, redness, itching or swelling where the drug is applied or taken.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I have widespread vitiligo for more than 6 months.
Select...
I have been diagnosed with non-segmental vitiligo.
Select...
I have noticeable white patches on my face due to vitiligo.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline and week 24
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline and week 24 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Change from Baseline in Facial Vitiligo Area Scoring Index (F-VASI) at Week 24
Number of Participants Who Discontinue Study Treatment Due to an AE
Number of Participants Who Experience an Adverse Event (AE)
Secondary outcome measures
Change from Baseline in Total Vitiligo Area Scoring Index (T-VASI) at Week 24

Trial Design

5Treatment groups
Experimental Treatment
Placebo Group
Group I: Extension: Dose 2Experimental Treatment2 Interventions
Participants receive SC MK-6194 regimen 2. Participants from the arms "Base Study: Dose 2" or "Base Study: Placebo" may be enrolled in this arm after completing participation in their original arm.
Group II: Extension: Dose 1Experimental Treatment1 Intervention
Participants receive SC MK-6194 dose regimen 1. Participants from the arms "Base Study: Dose 1" or "Base Study: Placebo" may be enrolled in this arm after completing participation in their original arm.
Group III: Base Study: Dose 2Experimental Treatment2 Interventions
Participants receive SC MK-6194 dose regimen 2.
Group IV: Base Study: Dose 1Experimental Treatment1 Intervention
Participants receive subcutaneous (SC) MK-6194 dose regimen 1.
Group V: Base Study: PlaceboPlacebo Group1 Intervention
Participants receive an SC placebo regimen.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Placebo
1995
Completed Phase 3
~2670

Find a Location

Who is running the clinical trial?

Merck Sharp & Dohme LLCLead Sponsor
3,892 Previous Clinical Trials
5,060,981 Total Patients Enrolled
Medical DirectorStudy DirectorMerck Sharp & Dohme LLC
2,777 Previous Clinical Trials
8,064,239 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Would I qualify to be a participant in this research study?

"Patients must be afflicted with vitiligo and between 18-75 years to take part in this study; a total of 165 participants are needed."

Answered by AI

Is there any risk associated with the Base Study: Dose 1 protocol?

"Our assessment of Base Study: Dose 1 on a safety scale from 1 to 3 is 2, as there is existing evidence for its protection but none verifying it's efficacy."

Answered by AI

Are there multiple health centers in this state conducting the clinical research?

"The participating medical institutions include Virginia Clinical Research Inc. (Site 0109) in Norfolk, VA; the Vitiligo & Pigmentation Institute of Southern California ( Site 0115) in Los Angeles, CA; Cahaba Dermatology & Skin Health Center ( Site 0127) in Birmingham, AL plus an additional 7 sites across the United States."

Answered by AI

Are there still opportunities for individuals to participate in this research endeavor?

"According to clinicaltrials.gov, the recruitment period for this medical trial is ongoing - it was first posted on November 27th 2023 and recently updated December 7th of the same year."

Answered by AI

Does this clinical study accommodate geriatric individuals?

"Prerequisites for enrollment in this trial are an age between 18 and 75 years."

Answered by AI

What is the current patient cohort of this research investigation?

"This medical study requires 165 patients who meet the specific criteria to take part. They can enrol at Virginia Clinical Research, Inc., in Norfolk (Site 0109), and The Vitiligo & Pigmentation Institute of Southern California, Los Angeles (Site 0115)."

Answered by AI

Who else is applying?

What site did they apply to?
The Vitiligo & Pigmentation Institute of Southern California ( Site 0115)
Hamzavi Dermatology - Canton ( Site 0101)
What portion of applicants met pre-screening criteria?
Met criteria
Recent research and studies
clinicaltrials.govStudy
A Clinical Study of MK-6194 for the Treatment of Vitiligo (MK-6194-007)
2023. "A Clinical Study of MK-6194 for the Treatment of Vitiligo (MK-6194-007)". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06113328.
All > Vitiligo > Nashville
~110 spots leftby Sep 2025
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